A Comparison of Two Daily Disposable Soft Contact Lenses

NCT ID: NCT02427477

Last Updated: 2018-06-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-04-30

Brief Summary

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Approximately 120 subjects will be comparing two soft contact lenses for one week each.

Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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senofilcon A/ delefilcon A/ senofilcon A

Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.

Group Type EXPERIMENTAL

senofilcon A

Intervention Type DEVICE

Subjects will wear the contact lenses in both eyes for seven days

delefilcon A

Intervention Type DEVICE

Subjects will wear the contact lenses in both eyes for seven days

delefilcon A/senofilcon A/ delfilcon A

Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

Subjects will wear the contact lenses in both eyes for seven days

delefilcon A

Intervention Type DEVICE

Subjects will wear the contact lenses in both eyes for seven days

Interventions

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senofilcon A

Subjects will wear the contact lenses in both eyes for seven days

Intervention Type DEVICE

delefilcon A

Subjects will wear the contact lenses in both eyes for seven days

Intervention Type DEVICE

Other Intervention Names

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senofilcon A Prototype Dailies Total 1

Eligibility Criteria

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Inclusion Criteria

1. The subject must read, understand, and sign the Statement of Informed Consent, and receive a fully executed copy of the form.
2. The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol.
3. The subject be between (and including) 18 and 39 years of age.
4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
6. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

1. Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any ocular infection.
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Monovision, multifocal, toric, or extended wear contact lens correction.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montgomery, Alabama, United States

Site Status

Jacksonville Beach, Florida, United States

Site Status

Longwood, Florida, United States

Site Status

Winter Park, Florida, United States

Site Status

Westerville, Ohio, United States

Site Status

Salem, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CR-5698

Identifier Type: -

Identifier Source: org_study_id

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